RecruitingRecruiting
Left Bundle Branch Area Pacing in Heart Failure Patients With Ejection Fraction Below Normal
NCT06148571 · Seoul National University Hospital
In plain English
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About this study
While cardiac resynchronization therapy remains the mainstay for advanced HF, it is not always feasible due to unfavorable anatomy of coronary sinus or pacing characteristics. In such cases, left bundle branch area pacing itself or left bundle optimized cardiac resynchronization therapy could be a rescue therapy for failed or unsuccessful biventricular cardiac resynchronization therapy. However, the efficacy and safety of left bundle branch area pacing (or left bundle optimized cardiac resynchronization therapy) as rescue therapy for biventricular cardiac resynchronization therapy is largely hypothetic and lack concrete evidence still.
Therefore, there is an unmet need for the registry purposed for left bundle branch area pacing among heart failure with mid-range (or mildly reduced) ejection fraction and heart failure with reduced ejection fraction patients to investigate its efficacy and safety.
This study aims to investigate the efficacy and safety of left bundle branch area pacing in heart failure patients with ejection fraction below normal using Selectra catheters.
Eligibility criteria
Inclusion Criteria:
* Patients previously diagnosed with heart failure with mid-range(or mildly reduced) ejection fraction and heart failure with reduced ejection fraction, which was documented by an appropriate echocardiographic study (Left ventricle ejection fraction \<50%), and
* Patients with indications of cardiac pacing or cardiac resynchronization therapy
Exclusion Criteria:
* Patients aged less than 19 years.
* Pregnant.
* Patients with an expected life expectancy of less than 1 year.
* Patients with a mechanical valve for the tricuspid valve.
* Patients who need atrial pacing only.
* Patients who are not capable of receiving a transvenous pacemaker for any reason.
Study design
Enrollment target: 200 participants
Age groups: adult, older_adult
Timeline
Starts: 2023-10-10
Estimated completion: 2026-12-31
Last updated: 2026-05-19
Interventions
Device: left bundle branch area pacing
Primary outcomes
- • The acute success rate of left bundle branch area pacing (The day of the procedure)
- • Acute complications related to the procedures (7 days from the procedure)
Sponsor
Seoul National University Hospital · other
Contacts & investigators
ContactEue-Keun Choi, M.D. Ph.D. · contact · choiek417@gmail.com · 82-2-2072-0688
InvestigatorEue-Keun Choi, M.D. Ph.D. · principal_investigator, Seoul National University Hospital
All locations (1)
Seoul National University HospitalRecruiting
Seoul, Jongno-gu, South Korea